Copy
Issue 27 - July 2019
Email not displaying correctly? View it in your browser.
Welcome to the July edition of Tablets, a prescribing newsletter produced monthly by the Medicines Management team at Midlands and Lancashire CSU.

Contents

Formulary Update

New Medicines 

BLACK EVOLOCUMAB injection (Repatha SureClick®▼) for reduction of cardiovascular risk in adults with established atherosclerotic cardiovascular disease
The Pan Mersey Area Prescribing Committee does not recommend the prescribing of EVOLOCUMAB injection (Repatha SureClick®▼) for reduction of cardiovascular risk in adults with established atherosclerotic cardiovascular disease.

GREEN ERTUGLIFLOZIN film-coated tablets (Steglatro®▼)
The Pan Mersey Area Prescribing Committee recommends the prescribing of ERTUGLIFLOZIN film-coated tablets (Steglatro®▼) in a triple therapy regimen for treating type 2 diabetes in accordance with NICE TA583.


Formulary

BLACK VORICONAZOLE (VFEND®) or POSACONAZOLE (Noxafil®) for allergic bronchopulmonary aspergillosis
The Pan Mersey Area Prescribing Committee does not recommend the prescribing of voriconazole or posaconazole, by GPs or specialists, for Allergic Bronchopulmonary Aspergillosis.

BLACK RUBEFACIENTS (excluding topical NSAIDS and capsaicin)
The Pan Mersey Area Prescribing Committee does not recommend the prescribing of RUBEFACIENTS (excluding topical NSAIDS and capsaicin).

GREY BUDESONIDE (Jorvaza) for eosinophilic oesophagitis
Clarification of removal of off-label budesonide nebules formulary entry (RAG designation Red). May continue to be prescribed by secondary care pending outcome of NICE appraisal of Jorvaza formulation (currently designated Grey) specifically licensed for this indication.

RED MEXILETINE (Namuscla) for non – dystrophic myotonia
Clarification that the Namuscla formulation is commissioned by NHS England, and that unlicensed mexiletine formulation will continue to be prescribed for ventricular arrhythmias, as Namuscla is clinically unsuitable.

RED RITUXIMAB (Truxima®▼, Rixathon®▼) for immune (idiopathic) thrombocytopenic purpura
The Pan Mersey Area Prescribing Committee recommends the prescribing of rituximab by specialists only, for immune (idiopathic) thrombocytopenic purpura before romiplostin and eltrombopag.

AMBER RETAINED ITRACONAZOLE for allergic bronchopulmonary aspergillosis
The Pan Mersey Area Prescribing Committee recommends the prescribing of ITRACONAZOLE, for Allergic Bronchopulmonary Aspergillosis.

AMBER RETAINED CABERGOLINE for Parkinson’s disease
Addition of 1mg and 2mg tablets. Cost saving compared to use of 500microgram tablets.

AMBER INITIATED ACICLOVIR eye ointment for Herpes simplex eye infection
Removal from formulary – discontinued. Ganciclovir eye gel alternative formulary option (not recommended in pregnancy).

AMBER INITIATED OMEGA-3 FATTY ACIDS for prevention of pancreatitis in hypertriglyceridaemia
Re-instatement in formulary of omega-3 fatty acids for hypertriglyceridaemia (>10mmol/L) for prevention of pancreatitis, in addition / instead of statins and fibrates where these are ineffective/not tolerated.

AMBER INITIATED STRONTIUM RANELATE for osteoporosis
Now commercially available following previous discontinuation. Annual cost per patient £650 but minimal anticipated cost impact due to low patient numbers.

AMBER RECOMMENDED LATANOPROST and TIMOLOL eye drops (Fixapost) for glaucoma
Less costly preservative-free prostanoid agonist + beta-blocker combination eye drop option

GREEN SEMAGLUTIDE for type 2 diabetes
Additional GLP-1 mimetic option. Cost is comparable to current formulary options.

GREEN TRIMOVATE ointment for dermatoses
Re-instatement in formulary following resolution of long-term supply issue.


Guidelines

Asthma - primary care paediatric guidelines
Updated versions of current guidelines with simplified preferred choice inhaler options. Based on BTS asthma guidelines.

Headache pathway
Update of current guideline incorporating new RAG designation for valproate in women of child-bearing potential - amber retained (not routinely recommended in headache prevention in women of child-bearing potential)

Testosterone for men with secondary androgen deficiency, guidance for primary care prescribing
Guidance on symptoms and testosterone levels suggesting where referral to specialist may be appropriate, designation of testosterone RAG, and prescribing guidance for primary care clinicians.

Safety 

INSULIN: reducing errors in prescribing and administration
Single document replaces previous safety advice for high strength insulin, biosimilar insulin, prescription sheet and record chart.

VALPROATE: safe prescribing and dispensing to girls of any age and women of childbearing potential
Minor update for noting. Updated link to new risk assessment form. Wording changes to reflect specialist role in assessing the need for contraception.

Safety Updates

Please click here for a summary of safety updates and SPC updates in June.

Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Medicines and Healthcare products Regulatory Agency | 20 June 2019
MHRA advises that DOACs are not recommended in patients with antiphospholipid syndrome, particularly high-risk patients (those who test positive for all 3 antiphospholipid tests — lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2 glycoprotein I antibodies).

GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued
Medicines and Healthcare products Regulatory Agency | 20 June 2019 
It is advised that blood glucose self-monitoring is necessary when adjusting the dose of insulin, particularly when GLP-1 receptor agonist therapy is initiated, and insulin is reduced. Any insulin dose reduction should be done in a stepwise manner.

Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women
Medicines and Healthcare products Regulatory Agency | 20 June 2019
New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support Pregnancy Prevention Programme in women on acitretin, alitretinoin and isotretinoin. Advice about risk of neuropsychiatric reactions has been made consistent for all oral retinoids.

Registration of GP Practices with the Central Alerting System
Medicines and Healthcare products Regulatory Agency | 24 June
In support of improving patient safety alerting system resilience for general practice, there are new contractual requirements for practices to register a practice email address with the CAS by 01 October 2019, and monitor the email account to act on CAS alerts where appropriate.

Falsified Medicines Directive Alert Class 2, Action Within 48 Hours, B & S Healthcare, Multiple Parallel Imported Products.
Central Alerting System | 27 June 2019
Recall of medicines that have been taken out of the regulated medicines supply chain during distribution and later re-introduced.  The products were parallel imported into the UK from Italy by B & S Healthcare. The products are believed to be legitimate medicines.

Prescribing News

NICE Guidance Updates June 2019

There have been three guidelines and one technology appraisal published in June 2019 by the National Institute for Clinical Excellence which has impact upon primary care.

The Urinary incontinence and pelvic organ prolapse in women guideline has been updated. The guideline covers the assessment and management of urinary incontinence and pelvic organ prolapse in women aged 18 and over. The guideline also covers complications associated with mesh surgery for these conditions. Two recommendations on use of synthetic polypropylene or biological mesh insertion for women with recurrent anterior vaginal wall prolapse have been withdrawn.

The Hypertension in pregnancy has been published and replaces previous guidance. The guideline covers diagnosing and managing hypertension, including pre-eclampsia, during pregnancy, labour and birth. It also includes advice for women with hypertension who wish to conceive and women who have had a pregnancy complicated by hypertension. The guideline aims to improve care during pregnancy, labour and birth for women and their babies.  

The Depression in children and young people guideline has been published and replaces previous guidance. The guideline covers identifying and managing depression in children and young people aged 5 to 18 years. Based on the stepped- care model, it aims to improve recognition and assessment and promote effective treatments for mild and moderate to severe depression.

A technology appraisal, The Ertugliflozin with metformin and dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes has been published. The appraisal recommends ertugliflozin as an option for treating type 2 diabetes in adults when diet and exercise alone do not provide adequate glycaemic control, only if:
  • The disease is uncontrolled with metformin and a DPP-4 inhibitor, and a sulfonylurea or pioglitazone is not appropriate.
Clinicians should be aware of these guidelines and implement any necessary changes to their practice. 
 

CKS Updates June 2019

During the month of June 2019, the following Clinical Knowledge Summaries were published or updated:  
There have been minor restructures to the topics listed above. The Bowel screening topic has been updated regarding the adoption of the faecal immunochemical test (FIT). The Cellulitis – acute topic has been updated to now recommend doxycycline as choice of antibiotic in those who are taking a statin and intolerant to penicillin antibiotics. The Developmental rheumatology in children is a new topic and the Premenstrual syndrome topic has been updated to clarify the definition of and information on severity of premenstrual syndrome.
 
Clinicians can use the updated and new information when reviewing patients.
 

Useful Resources
This section has been adapted from www.prescriber.org.uk

Drug Availability

Products in short supply and product discontinuations

The following links provide prescribers with up to date information on commonly prescribed products which are currently in short supply from the manufacturers. The information held on these lists is not exhaustive. Availability can vary geographically and also between wholesalers. Up-to-date information should be sought from manufacturers, local community pharmacies and suppliers.


DHSC report July 2019

The following links provide prescribers with up to date information on commonly prescribed products which are currently in short supply from the manufacturers.


New Issues

Orals

Cefuroxime 125mg/5ml suspension (Zinnat)
GSK the sole supplier of cefuroxime 125mg/5ml suspension will be out of stock until mid-August 2019. Cefuroxime 125mg tablets are available from GSK. UKMi have advised that tablets can be crushed and dispersed for oral administration. However, please note that doing so is considered off-label use.

Disopyramide 100mg tablets

All UK suppliers of disopyramide 100mg tablets are out of stock. Sanofi has a resupply date of mid- August and Mylan now has a resupply date of early August. A supply disruption alert has been issued via MHRA’s CAS, which includes information on the issue and actions to be taken. Please see link below: 

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102869

Indivina (Estradiol/ Medroxyprogesterone) 2mg/5mg tablets

(please also see HRT products section)
Orion, the sole manufacturer of Indivina 2mg/5mg HRT tablets have reported that they will be out of stock of this strength until mid-August 2019. Orion have advised there is sufficient stock of Indivina 1mg/2.5mg tablets (lower strength) to cover an uplift in demand until the higher strength is back in stock. Please note: patients normally prescribed the higher strength of Indivina (2mg/5mg), would require two tablets of the lower strength (1mg/2.5mg) to ensure equivalence.

Joyrides (Hyoscine Hydrobromide 150 microgram Tablets)

Teva have a manufacturing issue and are currently out of stock of Joyrides until August 2019. Bayer also supply this product (Kwells Kids) and are in stock.

Salbutamol 2mg/5ml syrup

Both suppliers of salbutamol 2mg/5mL syrup, GSK and Pinewood, are currently out of stock of Salbutamol 2mg/5ml syrup. GSK, (Ventolin) have advised a resupply date of early August 2019 - Pinewood are currently unable to advise a resupply date. 

Specialist importers have identified unlicensed stock of salbutamol 2mg/5ml syrup they can bring into the UK from abroad.  However, please note lead times for these products vary. Salbutamol 2mg and 4mg tablets are also available from Accord UK. UKMI have prepared the following clinical memo, which is available on the SPS website:
https://www.sps.nhs.uk/articles/shortage-of-salbutamol-syrup-2mg-5ml/

Nardil (phenelzine sulfate) 15mg tablets (MAOI)

Kyowa Kirin, the sole supplier of Nardil (phenelzine sulfate) 15mg tablets in the UK, have informed the Department of Health and Social Care that due to manufacturing delays, Nardil will be out of stock from the beginning of August until at least the end of October 2019. DHSC have contacted specialist importer companies, who have advised that unlicensed imports can be sourced from abroad. 

UK Medicine Information have also published guidance on management including the need for specialist referral to mental health teams if unlicensed supplies of phenelzine sulfate 15mg tablets are deemed unsuitable: https://www.sps.nhs.uk/articles/shortage-of-phenelzine-15mg-tablets-nardil/


Local Action required:


Please share this information with relevant networks locally including GP practices, community pharmacies and community mental health services.

For patients who do not have sufficient supplies of Nardil (phenelzine sulfate) 15mg tablets for the duration of the expected out of stock period, clinicians should consider prescribing an unlicensed preparation of phenelzine sulfate 15mg tablets as soon as possible in order to avoid abrupt withdrawal. Clinicians will need to work with local pharmacies to understand more about the specific unlicensed products that can be sourced and associated lead times. In order to minimise the disruption this may cause locally in terms of patients seeking GP appointments, GP practices may want to consider using local IT systems to identify patients who may be impacted by this shortage and to manage these patients by prescribing unlicensed supplies or referring back to a specialist team in good time, where appropriate.

Clinicians should refer to the UKMI memo for advice on alternatives:  
https://www.sps.nhs.uk/articles/shortage-of-phenelzine-15mg-tablets-nardil/


Other Preparations


Skinoren (azelaic acid) 20% cream
Bayer, sole suppliers, are out of stock of Skinoren 20% cream with resupply expected in mid-October 2019. The license will be transferred to Leo Pharma from 1st July 2019.

UKMI has provided the following advice on alternative options:
  • Azelaic acid has antimicrobial and anticomedonal properties and is considered less likely to cause local irritation than benzoyl peroxide; it is an alternative in facial acne if benzoyl peroxide or topical retinoids are poorly tolerated.
  • There are other topical products available and choice will be determined by what patient has already tried/ tolerated. Systemic treatments are also an option
  • Please refer to local formulary or to following guidelines for alternative treatment options:
  • NICE Clinical Knowledge Summary (April 2018): https://cks.nice.org.uk/acne- vulgaris#!scenarioRecommendation
  • Primary Care Dermatology Society ( April 2019): http://www.pcds.org.uk/clinical- guidance/acne-vulgaris#management
Tilade (nedocromil sodium 2mg/dose) Inhaler
Sanofi, the sole supplier of Tilade inhaler, are currently out of stock until mid-August. UKMI have advised that Intal (Sodium Cromoglicate-5mg/dose) is interchangeable and sufficient stock is available.

Please note differences in maintenance doses for these inhalers: -
  • Sodium cromoglicate (Intal) - Initially TWO puffs (10 mg) four times a day, additional dose may also be taken before exercise, increased if necessary, to TWO puffs (10 mg) six to eight times a day. Maintenance dose is ONE puff (5 mg) four times a day.
  • Nedocromil sodium (Tilade)- Initially TWO puffs (4 mg) four times a day, when control achieved, may be possible to reduce to twice daily.
  • For further information visit: https://cks.nice.org.uk/asthma#!prescribingInfoSub:21
     

Ongoing Issues:
For advice on ongoing issues please click here

Drug Tariff Changes

This summary document shows the top 10 price changes since last month, the top 25 changes compared to three months ago, and the top 50 since last year. 

Tell me more about drug tariff price changes

Antimicrobial Updates

Please click here for a full summary of antimicrobial related guidelines and SPC updates in June.

Syphilis: Public Health England action plan
Public Health England | 04 June

Updated Clostridium difficile infection objectives issued
NHS Improvement | 04 June

Avian influenza: guidance for managing human cases
Public Health England | 04 June

Winter 2019 to 2020 Flu vaccination: who should have it and why
Public Health England | 06 June

Increasing influenza immunisation uptake among children – leaflet for general practice
Public Health England | 07 June

Assessment of Antibiotic Treatment of Cellulitis and Erysipelas: A Systematic Review and Meta-analysis
JAMA Dermatology | 13 June

Documents relating to human papillomavirus (HPV) vaccination programme
Public Health England | 13 June

Updated guidelines on post-exposure prophylaxis for measles issued
Public Health England | 18 June

Added value and cascade effects of inflammatory marker tests in UK primary care: a cohort study from the Clinical Practice Research Datalink
British Journal of General Practice | 19 June

Use of multiple inflammatory marker tests in primary care: using Clinical Practice Research Datalink to evaluate accuracy
British Journal of General Practice | 19 June

Pneumococcal conjugate vaccines for preventing acute otitis media in children
Cochrane Database of Systematic Reviews | 20 June

Assessment of the Appropriateness of Antibiotic Prescriptions for Infection Prophylaxis Before Dental Procedures, 2011 to 2015
JAMA Network Open | 20 June

Head‐to‐head oral prophylactic antibiotic therapy for chronic obstructive pulmonary disease
Cochrane Collaboration | 24 June

Draft NICE guideline on antimicrobial prescribing for leg ulcer infection out for consultation
National Institute for Health and Care Excellence | 26 June

Emergency antibiotic supplies via NHS Urgent Medicines Supply Advanced Service (NUMSAS) on the rise
Pharmaceutical Journal | 26 June

Too clean or not too clean? The Case for Targeted Hygiene in the Home and Everyday Life
Royal Society for Public Health | 27 June

HPV universal vaccination: guidance for health professionals
Public Health England | 28 June
Please note that the information in this newsletter is correct at the time of publication.
Clinicians should always refer to the most up to date information.

Contacts
Kieron Donlon: kieron.donlon1@nhs.net - 0151 296 7076 


Copyright © 2018 Midlands & Lancashire Commissioning Support Unit, All rights reserved.

Our mailing address is:
MLCSU.Tablets@nhs.net

unsubscribe from this list | update your preferences

Email Marketing Powered by Mailchimp